LINX Reflux Management System in Subjects With GERD Who Have Previously Undergone a Laparoscopic Sleeve Gastrectomy

INCLUSION CRITERIA

Subjects included in the study must meet all the following criteria:

• Age >22 years
• Laparoscopic sleeve gastrectomy (LSG) for obesity >12 months prior to proposed device implantation date.
• Subject is a surgical candidate, i.e. is able to undergo general anesthesia and laparoscopic surgery.
• Documented typical symptoms of GERD for longer than 6 months (regurgitation or heartburn which is defined as a burning epigastric or substernal pain which responds to acid neutralization or suppression).
• Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
• Total distal ambulatory esophageal pH must meet the following criteria: pH 4.5% of the time. Note: Subjects shall have discontinued any GERD medications for at least 7 days prior to testing, with the exception of antacids up to the morning of testing.
• Subjects with symptomatic improvement on PPI therapy demonstrated by a GERD-HRQL score of 15 off PPI, or subjects with a >6 point improvement when comparing their on PPI and off PPI GERD-HRQL scores.
• GERD symptoms, in absence of PPI therapy (minimum 7 days).
• If the subject is of child bearing potential must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
• Subject is willing and able to cooperate with follow-up examinations
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form.

EXCLUSION CRITERIA

Subjects should be excluded from the study based on the following criteria:

• The procedure is an emergency procedure.
• Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
• Presence of ˃3 cm hiatal hernia as determined by endoscopy or barium esophagram.
• Subject had any major complications related to the laparoscopic sleeve gastrectomy that may interfere with, or increase the risks of the LINX procedure (such as, but not limited to, leaks from the gastric remnant and infection at the sleeve gastrectomy)
• Plans to surgically revise the gastric pouch (either known preoperatively or decided intraoperatively)
• Currently being treated with another investigational drug or investigational device.
• Suspected or confirmed esophageal or gastric cancer or prior gastric or esophageal surgery or endoscopic intervention for GERD (with the exception of sleeve gastrectomy).
• Distal amplitude 35.
• Symptoms of dysphagia more than once per week within the last 3 months.
• Diagnosed with Scleroderma.
• Diagnosed with an esophageal motility disorder such as but not limited to achalasia, nutcracker esophagus, or diffuse esophageal spasm or hypertensive LES.
• Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.)
• Subject has esophageal or gastric varices
• History of/or known Barrett's esophagus. Note: The diagnosis of Barrett's esophagus requires both endoscopic and histologic evidence of metaplastic columnar epithelium. Endoscopically, there must be columnar epithelium within the esophagus. Histologically, the epithelium must be metaplastic, as defined by the presence of goblet cells.by
• Subject cannot understand trial requirements or is unable to comply with follow-up schedule
• Pregnant or nursing, or plans to become pregnant during the course of the study.
• Any reason which the Investigator believes may cause the subject to be non-compliant with or unable to meet the protocol requirements.
• Subject has an electrical implant or metallic, abdominal implants.